FDA 510(k)

Oximeter

Número K: K173045 · 2018-06-05

RequerenteShenzhen Greatmade Tech Limited

Data da decisão2018-06-05

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Greatmade Tech Limited. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K173045. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Oximeter?

Oximeter is a medical device that received FDA 510(k) clearance on 2018-06-05. The listed applicant is Shenzhen Greatmade Tech Limited. The 510(k) number is K173045.

When did Oximeter receive FDA 510(k) clearance?

Oximeter received FDA 510(k) clearance on 2018-06-05, under 510(k) number K173045.

Who is the listed applicant for Oximeter?

The FDA 510(k) record lists Shenzhen Greatmade Tech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oximeter?

The FDA product code for Oximeter is DQA.

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